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Effectiveness of Tricortin 1000 in Patients Affected by Chronic Low Back Pain

NCT04585334 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-10-27

No results posted yet for this study

Summary

PAES, double blind, double dummy, multicenter, randomized, controlled clinical study to demonstrate superiority of Tricortin 1000 over placebo in improvement in pain relief as change from baseline to 15 days in patients with chronic low back pain (LBP).

Conditions

  • Low Back Pain, Mechanical

Interventions

DRUG

Tricortin 1000

Tricortin 1000 \[2 mL ampoules containing 12 mg of phospholipids and 1 mg of Vitamin B12 (Cyanocobalamin)\] will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2) plus Diclofenac sodium medicated plaster placebo will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications.

DRUG

Itami

Diclofenac sodium 140 mg medicated plaster (Itami®) will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications plus Tricortin 1000 placebo (2 mL ampoules) will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2).

DRUG

Placebo

Tricortin 1000 placebo (2 mL ampoules) will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2) plus Diclofenac sodium medicated plaster placebo will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications.

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    lead INDUSTRY

Principal Investigators

  • Nicola Giordan · Fidia Farmaceutici s.p.a.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585334 on ClinicalTrials.gov